Maze Therapeutics Inc. (MAZE), a clinical-stage biopharmaceutical company, has announced positive topline data from its phase 2 trial of MZE829 in patients with broad APOL1-mediated kidney disease, dubbed HORIZON.
APOL1-mediated kidney disease (AMKD) is a subset of chronic kidney disease linked to variants in the APOL1 gene, which is more common in people of African ancestry, and is estimated to affect over one million patients in the United States alone.
For the topline analysis, 15 patients were enrolled in the HORIZON study, and all were included in a safety and tolerability analysis. Among all enrolled patients, eight were diagnosed with AMKD without diabetes, including five with biopsy-confirmed Focal Segmental Glomerulosclerosis (FSGS), and seven were diagnosed with AMKD with diabetes.
Twelve patients were evaluated for efficacy, i.e., urine albumin-to-creatinine ratio (uACR) reduction, which is a key measure of kidney health.
According to the results, reported today, in the phase 2 HORIZON trial, treatment with MZE829 led to a clinically meaningful mean reduction in proteinuria, with a 35.6% average decrease in uACR at week 12 among patients with broad APOL1-mediated kidney disease, and 50% of patients achieving more than a 30% reduction in uACR.
In patients with Focal Segmental Glomerulosclerosis, treatment with MZE829 led to a mean reduction in uACR of 61.8%.
Among patients with APOL1-mediated kidney disease (AMKD) without diabetes, MZE829 resulted in a clinically meaningful mean uACR reduction of 48.6%. Among patients with AMKD and diabetes, five were evaluable per protocol for efficacy, with two achieving at least a 30% reduction in uACR.
MZE829 was well tolerated across all doses, and no serious adverse events (AEs) or severe treatment-related adverse events (TRAEs) were reported, added the company.
Based on the encouraging results, the company plans to advance MZE829 to a pivotal program, while continuing to enroll in the HORIZON trial.
In other news, the company announced financial results for the fourth quarter and year ended December 31, 2025, highlighting recent progress and business updates.
Pipeline Update
In addition to MZE829, the company is developing MZE782 in phenylketonuria (PKU) and chronic kidney disease (CKD), and MZE001 in Pompe disease. Shionogi & Co., Ltd. acquired exclusive worldwide rights for MZE001 from Maze in 2024, and this compound now goes by the name S-606001.
-- MZE782 is expected to enter phase 2 proof-of-concept trials for plasma phenylalanine reduction in PKU by mid-2026 and for proteinuria reduction in CKD in the second half of 2026.
-- Shionogi initiated a global phase 2 clinical trial of S-606001 in Pompe disease, dubbed ESPRIT, earlier this month, subsequently enabling Maze to achieve a $20 million milestone under its collaboration agreement with Shionogi.
Financial Scorecard
For the quarter ended December 31, 2025, the company's net loss widened to $34.6 million from $29.6 million for the same quarter in 2024.
For the full year of 2025, the net loss was $131.1 million, compared with net income of $52.2 million in 2024.
The company held cash, cash equivalents and marketable securities of $360.0 million at year-end 2025, sufficient to fund operations into 2028 based on its current business plan.
When we alerted readers to MAZE on May 28, 2025, it was trading around $11.
The stock closed yesterday's trading at $49 and is down over 25% at $36.50 in premarket trading today.
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Business News
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